Safety and Efficacy of IQP-MM-101 in Reducing Symptoms of Diarrhoea

Not Applicable

Completed

Conditions: Diarrhoea

Interventions: Device: IQP-MM-101

Registration Number: NCT01969214

Lead Sponsor: InQpharm Group

Brief Summary: Diosmectite in IQP-MM-101 has been used for diarrhoea control. Backed by data from several studies demonstrating their efficacy, the investigators are conducting this study to look into the efficacy and safety of IQP-MM-101 in diarrhoea control.

Detailed Description: The clinical study was intended to evaluate the safety and the potential reduction of diarrhoea recovery time post 1st intake of IQP-MM-101 in an open label, single arm, multicentre study over a 72 hours period. There were 2 clinic visits: the screening visit and final visit.

At baseline visit (visit 1), written informed consents were collected. Each patients were given a diary and the following data were collected: demographics, vital signs, physical examination results, use of concomitant medication, previous medical history, and case history of the acute diarrhoea episode including date of first watery stool, number of stools over the past 24 hours, and presence of other associated symptoms over the past 24 hours (nausea, vomiting, abdominal pain).

Subjects recorded the following data in the diary: date and hour of bowel movement, stool consistency (Bristol stool scale) presence of symptoms such as nausea, vomiting, abdominal pain and study IP consumption (number, date, and time of tablets taken) and time of vomiting (if any) each day during the treatment period. Additionally, subjects recorded the time absent from work and a subjective evaluation of their "energy for everyday life".

Visit 2 took place after 72 hours treatment period. Following data was collected:

* Vital signs, physical examination

* Adverse events

* Use of concomitant medication

* Compliance (returned IP and diary)

* Global evaluation of efficacy and safety by subjects and investigators

During the 72-hour treatment period, all subjects were instructed to consumed IQP-MM-101 according to the following dosage: one (1) tablet, three (3) times a day dissolved in at least 125mL (half a glass) of water.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 101

Inclusion Criteria

Age 18 to 65 years
Good general health
Acute diarrhoea episode defined as at least three watery stools per 24 hours over a period of 48 hours or less
Acute diarrhoea of presumed infectious origin
Patients with usually normal bowel movements (defecations) before onset of diarrhoea, that is, at least three normal stools per week and three or less normal stools per day
Negative pregnancy test (ß HCG-test) for women with child bearing potential
Written informed consent is a prerequisite for subject enrollment

Exclusion Criteria

Known sensitivity to the ingredients of the device
Fever >38,5◦C
Blood or pus in stools
Dehydration requiring intravenous rehydration
History of chronic diarrhoea (three or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months)
Use of antidiarrhoeal agents over the month prior to baseline
Diarrhoea possibly induced by antibiotics, laxative agents, thyroid hormones, or colchicine
Irritable bowel syndrome
Any other acute or chronic disease that could interfere with the evaluation of study device
Females who are pregnant or lactating
Subjects who have participated in another clinical trial in the 30 days before treatment period
Inability to comply
Presence of other factor(s) that, in the investigator's judgement, should preclude subject participation

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IQP-MM-101	IQP-MM-101	Dissolve the effervescent tablets in half a glass of water,to be taken orally 1 tablet, 3 times a day

Primary Outcome Measures

Name	Time	Method
Time (in Hours) Between the 1st Intake of IQP-MM-101 and First Formed or Hard Stool (Type 6 to 1) Followed by a Non Watery Stool (Type 6 to 1)	96 hours	In essence the definition of recovery would be two consecutive non-watery stool (type 6 to 1) when stool before 1st intake of IQP-MM-101 is primarily watery (type 7).

Secondary Outcome Measures

Name	Time	Method
Time (Hours) From the First Intake to the Last Watery Stool	96 hours	The last watery stool was assumed as the first-non watery stool
Number of Watery Stools	96 hours
Stool Frequency	96 hours	The mean number of daily defecation.
Percentage of Patients Having Recovered Within a Certain Time Period (Defined as Having Achieved the Primary Efficacy Endpoint)	72 hours
Abdominal Pain	96 hours	Subjects feeling of abdominal pain was measured on visual analog scale of 0 - 100mm (no pain to severe pain).
Time Off From Work	1 week
Evaluation of Subjects' Energy Level	96 hours	The subjective measure of subjects' daily energy level was determined by severity of weakness felt by the subjects, measured on visual analog scale (0-100mm, 100mm being most severe weakness).
Global Evaluation of Safety and Efficacy by Subjects and Investigators	96 hours	The subjects and investigators will evaluate independently the safety of the investigational device (global scaled evaluation with "very good", "good", "moderate" and "poor").
Occurrence of Adverse Events (AEs)	96 hours
Associated Symptoms Such as Vomiting	96 hours
Stool Consistency	96 hours	Stool consistency is measured by Bristol Stool Form Scale 1-7. 1. Separate hard lumps, like nuts (hard to pass) 2. Sausage-shaped, but lumpy 3. Like a sausage but with cracks on its surface 4. Like a sausage or snake, smooth and soft 5. Soft blobs with clear cut edges (easy to pass) 6. Fluffy pieces with ragged edges, a mushy stool 7. Watery, no solid pieces, entirely liquid Stool consistency is the mean of the scale measured each day.
Severity of Nausea	96 hours	Subjects feeling of nausea was measured on visual analog scale of 0 - 100mm (no nausea to severe nausea).
Number of Daily Defecation	96 hours